An examination of the effects of a patient-designed-and-informed participant information sheet in comparison with a standard, researcher-designed information sheet on recruitment, retention and understanding: Protocol for a study-within-a-trial

Background: This protocol describes a double-blind, randomised non-inferiority study-within-a-trial (SWAT), comparing the effects of a patient-designed-and-informed participant information sheet with a standard, researcher-designed participant information sheet on recruitment, retention, decision certainty, participant information sheet understanding and likeability. The SWAT is part of a larger trial that aims to evaluate the feasibility and preliminary efficacy of a cognitive occupation-based programme for people with MS (COB-MS) on cognitive and daily functioning for people with multiple sclerosis. Methods: During the study, 120 people with multiple sclerosis will be randomly allocated to one of the two groups, where they will either receive a standard participant information sheet or a patient-designed participant information sheet. Recruitment and retention will be analysed, as well as decision certainty, likability and understanding. Discussion: Results will provide recommendations for recruitment, consent and retention for future trials, as well as shed some light on the factors influencing the understanding and likeability of a trial’s participant information sheet. Recommendations will also be made regarding patient and public involvement in developing and/or aiding the development of participant information sheets. Registration: SWAT: Northern Ireland Hub for Trials Methodology Research SWAT Repository Store (SWAT105). COB-MS trial: ISRCTN11462710.

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How to make study documents clear and relevant: the impact of patient involvement

BJPsych Open ◽

10.1192/bjo.2021.1040 ◽

2021 ◽

Vol 7 (6) ◽

Author(s):

Sagar Jilka ◽

Georgie Hudson ◽

Sonja M. Jansli ◽

Esther Negbenose ◽

Emma Wilson ◽

...

Keyword(s):

Public Involvement ◽

Patient And Public Involvement ◽

Mixed Methods Design ◽

Information Sheet ◽

Participant Information Sheet ◽

Before And After ◽

Research Document ◽

The Impact ◽

Participant Information ◽

Over Time

Background Patient and public involvement can improve study outcomes, but little data have been collected on why this might be. We investigated the impact of the Feasibility and Support to Timely Recruitment for Research (FAST-R) service, made up of trained patients and carers who review research documents at the beginning of the research pipeline. Aims To investigate the impact of the FAST-R service, and to provide researchers with guidelines to improve study documents. Method A mixed-methods design assessing changes and suggestions in documents submitted to the FAST-R service from 2011 to 2020. Quantitative measures were readability, word count, jargon words before and after review, the effects over time and if changes were implemented. We also asked eight reviewers to blindly select a pre- or post-review participant information sheet as their preferred version. Reviewers’ comments were analysed qualitatively via thematic analysis. Results After review, documents were longer and contained less jargon, but did not improve readability. Jargon and the number of suggested changes increased over time. Participant information sheets had the most suggested changes. Reviewers wanted clarity, better presentation and felt that documents lacked key information such as remuneration, risks involved and data management. Six out of eight reviewers preferred the post-review participant information sheet. FAST-R reviewers provided jargon words and phrases with alternatives for researchers to use. Conclusions Longer documents are acceptable if they are clear, with jargon explained or substituted. The highlighted barriers to true informed consent are not decreasing, although this study has suggestions for improving research document accessibility.

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A qualitative investigation of reasoning behind decisions to decline participation in a research intervention: A study-within-a-trial

Journal of Health Psychology ◽

10.1177/13591053211037736 ◽

2021 ◽

pp. 135910532110377

Author(s):

Christopher P Dwyer ◽

Anusha Moses ◽

Fionnuala M Rogers ◽

Dympna Casey ◽

Robert Joyce ◽

...

Keyword(s):

Multiple Sclerosis ◽

Chronic Illness ◽

Public Involvement ◽

Trial Recruitment ◽

Qualitative Investigation ◽

Structured Interviews ◽

Study Within A Trial ◽

Participation In Research ◽

Participant Information

The current study-within-a-trial explored individuals’ decisions to decline participation in research trialling a chronic illness-focused therapy (i.e. multiple sclerosis). Four themes were identified from seven semi-structured interviews with participation decliners and were confirmed by the host trial’s Patient & Public Involvement (PPI) panel: acknowledgement of the value of research; ‘fit’ of the study; misinterpretation of participant information; and ‘ignorance is bliss’ – discussed in light of theory and research. This study-within-a-trial extends research on trial recruitment and participation decline; while also suggesting that PPI can be utilised in both a practical and impactful manner.

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An empirical study on the preferred size of the participant information sheet in research

Journal of Medical Ethics ◽

10.1136/jme.2010.041871 ◽

2011 ◽

Vol 37 (9) ◽

pp. 557-562 ◽

Cited By ~ 22

Author(s):

E. E. Antoniou ◽

H. Draper ◽

K. Reed ◽

A. Burls ◽

T. R. Southwood ◽

...

Keyword(s):

Empirical Study ◽

Information Sheet ◽

Participant Information Sheet ◽

Participant Information

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Participant Information Sheet for the PhD Research of Jo Easton

Death in Custody ◽

10.1108/978-1-83909-025-720201022 ◽

2020 ◽

pp. 219-222

Keyword(s):

Information Sheet ◽

Participant Information Sheet ◽

Participant Information

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The mutual benefits of patient and public involvement in research: an example from a feasibility study (MoTaStim-Foot)

Research Involvement and Engagement ◽

10.1186/s40900-021-00330-w ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Alison M. Aries ◽

Paul Bailey ◽

Susan M. Hunter

Keyword(s):

Feasibility Study ◽

Portfolio Management ◽

Public Involvement ◽

Monitoring And Evaluation ◽

Patient And Public Involvement ◽

Grant Proposal ◽

Added Value ◽

Daily Diaries ◽

Working Together ◽

Participant Information

Abstract Background Patient and public involvement (PPI) in research has increased steadily over the last two decades and is now both expected and appropriately resourced by many funding bodies, including the National Institute for Health Research (NIHR). However, PPI in research occurs in many different capacities and numerous frameworks exist for reporting or appraising patient involvement activities. The aim of this article is to describe processes involving PPI contributions to an NIHR-funded mixed-methods feasibility study (MoTaStim-Foot). Details of PPI advisors’ input, from initial identification and prioritisation of research ideas, to research delivery and dissemination, are discussed. Methods Extensive PPI for MoTaStim-Foot is reported, with consideration of Research Design Service (RDS) advice for PPI for research, involving identifying and prioritising: design; grant proposal development; undertaking/managing research; analysing and interpreting; dissemination; implementation; monitoring and evaluation. Two PPI workshops were undertaken; success in meeting UK standards for public involvement was audited against specific success criteria by two researchers, with discussion and consideration regarding how well our PPI achieved inclusive opportunities, working together, support and learning, governance, communications and impact. How PPI can be improved for future trials was also considered. Although the advantages of PPI for researchers were considered, the benefits for PPI advisors were also analysed. Results UK standards for public involvement were achieved, along with seven relevant research processes suggested by the RDS. PPI advisor contributions: informed study design; contributed to successful funding; enhanced trial delivery by informing participant information sheets and daily diaries; added value through undertaking note-taker roles in focus groups and helping to analyse focus group transcripts; and assisted in dissemination. However, benefits were mutual with PPI advisors reporting feeling valued and respected, a sense of pride with renewed confidence and purpose in life. Conclusions Importance and value of PPI, to researchers and patient advisors, have been highlighted, reinforcing the benefits of working in partnership with PPI advisors. Trial registration ISRCTN 13676183; Central Portfolio Management System ID 30449. Registered 02/01/2015, https://www.isrctn.com/ISRCTN13676183.

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Enhanced participant information sheet for the recruitment of caregivers to a multicentre randomised trial

http://isrctn.com/ ◽

10.1186/isrctn15757498 ◽

2021 ◽

Author(s):

Valerie Smith

Keyword(s):

Randomised Trial ◽

Information Sheet ◽

Participant Information Sheet ◽

Participant Information

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Patient and family co-developed participant information to improve recruitment rates, retention, and patient understanding in the Rehabilitation Strategies Following Oesophago-gastric and Hepatopancreaticobiliary Cancer (ReStOre II) trial: Protocol for a study within a trial (SWAT)

HRB Open Research ◽

10.12688/hrbopenres.12950.1 ◽

2019 ◽

Vol 2 ◽

pp. 27 ◽

Cited By ~ 1

Author(s):

Linda O'Neill ◽

Peter Knapp ◽

Suzanne L. Doyle ◽

Emer Guinan ◽

Adwoa Parker ◽

...

Keyword(s):

Focus Group ◽

Cancer Survivorship ◽

Retention Rates ◽

Patient Understanding ◽

Phase Ib ◽

Recruitment And Retention ◽

Exercise Rehabilitation ◽

Link Type ◽

Study Within A Trial ◽

Participant Information

Background: Whilst the potential benefits of exercise rehabilitation in cancer survivorship are plentiful, recruitment to survivorship rehabilitation trials remains suboptimal. There is growing evidence that Public and Patient Involvement (PPI) initiatives can increase the rate of recruitment to research. This study within a trial (SWAT) will examine if participant information co-developed by patients and their families can lead to greater recruitment rates, retention and understanding of the Rehabilitation Strategies in Oesophago-gastric and Hepatopancreaticobiliary Cancer (ReStOre II) trial when compared to standard participant information. Methods: This SWAT will be carried out over two phases. Phase I will utilise qualitative methods to develop (Phase Ia) and refine (Phase Ib) the new participant information. Phase Ia will recruit up to 20 survivors of upper gastrointestinal or hepatopancreaticobiliary cancer, or their family members, to take part in a focus group or interview to develop the new participant information. Focus groups/interviews will be recorded, transcribed verbatim and analysed thematically. In Phase Ib, participants will return for a second focus group/interview to refine the participant information. Once finalised, the participant information will be submitted to ethics for approval. In Phase II, potential participants for the ReStOre II trial will be randomly assigned to receive either the standard or patient and family co-developed participant information. The two forms of participant information will be compared by recruitment and retention rates, and participant understanding of the trial (Decision-Making Questionnaire). Discussion: We anticipate that engaging with patients and their families to develop participant information will help to increase patient understanding of the ReStOre II trial and therefore recruitment and retention rates. The results of this SWAT will indicate the usefulness of this strategy for optimising recruitment to exercise rehabilitation trials in cancer survivorship. Registration: SWAT: Northern Ireland Hub for Trials Methodology Research SWAT Repository Store (SWAT-100). ReStOre II: ClinicalTrials.gov (NCT03958019).

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Does a video clip enhance recruitment into a parenting trial? Learnings from a study within a trial

Trials ◽

10.1186/s13063-020-04779-0 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Holly C. Mattock ◽

Rachael Ryan ◽

Christine O’Farrelly ◽

Daphne Babalis ◽

Paul G. Ramchandani

Keyword(s):

Randomised Trial ◽

Video Clip ◽

Small Sample ◽

Controlled Trials ◽

Information Sheet ◽

Main Trial ◽

Participant Information Sheet ◽

Video Condition ◽

To Receive ◽

Participant Information

Abstract Background Reaching recruitment targets in randomised controlled trials is a challenge. Media tools are increasingly used to engage participants, yet there is a paucity of research into the use of video to optimise recruitment. We therefore tested whether adding a participant information video clip to a standard participant information sheet improved recruitment into a parenting trial. Methods One hundred seven participants were randomised to receive either a participant information sheet (n = 51) or an informational video clip (n = 56) as part of an email contact following a screening phase. All participants went on to receive the information sheet as part of the existing consent procedure. Results The video condition did not increase the odds of recruitment into the trial, such that those in the video condition were significantly less likely to participate in the main trial (OR = 0.253, CI = 0.104–0.618, p = 0.003). Conclusion The introduction of a video clip into the recruitment stages of a parenting trial did not lead to an improvement in recruitment; however, the small sample size precludes definitive inferences. We offer reflections on challenges encountered in implementing the SWAT and suggestions for other researchers seeking to embed recruitment SWATs into similar trials. Trial registration Current controlled trials ISRCTN 58327365. Registered on 19 March 2015. SWAT registration SWAT 106; Effects of a video clip on recruitment into a randomised trial. Registered on 20 December 2016.

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Patient and family co-developed participant information to improve recruitment rates, retention, and patient understanding in the Rehabilitation Strategies Following Oesophago-gastric and Hepatopancreaticobiliary Cancer (ReStOre II) trial: Protocol for a study within a trial (SWAT)

HRB Open Research ◽

10.12688/hrbopenres.12950.2 ◽

2020 ◽

Vol 2 ◽

pp. 27

Author(s):

Linda O'Neill ◽

Peter Knapp ◽

Suzanne L. Doyle ◽

Emer Guinan ◽

Adwoa Parker ◽

...

Keyword(s):

Focus Group ◽

Cancer Survivorship ◽

Retention Rates ◽

Patient Understanding ◽

Phase Ib ◽

Recruitment And Retention ◽

Exercise Rehabilitation ◽

Link Type ◽

Study Within A Trial ◽

Participant Information

Background: Whilst the potential benefits of exercise rehabilitation in cancer survivorship are plentiful, recruitment to survivorship rehabilitation trials remains suboptimal. There is growing evidence that Public and Patient Involvement (PPI) initiatives can increase the rate of recruitment to research. This study within a trial (SWAT) will examine if participant information co-developed by patients and their families can lead to greater recruitment rates, retention and understanding of the Rehabilitation Strategies in Oesophago-gastric and Hepatopancreaticobiliary Cancer (ReStOre II) trial when compared to standard participant information. Methods: This SWAT will be carried out over two phases. Phase I will utilise qualitative methods to develop (Phase Ia) and refine (Phase Ib) the new participant information. Phase Ia will recruit up to 20 survivors of upper gastrointestinal or hepatopancreaticobiliary cancer, or their family members, to take part in a focus group or interview to develop the new participant information. Focus groups/interviews will be recorded, transcribed verbatim and analysed thematically. In Phase Ib, participants will return for a second focus group/interview to refine the participant information. Once finalised, the participant information will be submitted to ethics for approval. In Phase II, potential participants for the ReStOre II trial will be randomly assigned to receive either the standard or patient and family co-developed participant information. The two forms of participant information will be compared by recruitment and retention rates, and participant understanding of the trial (Decision-Making Questionnaire). Discussion: We anticipate that engaging with patients and their families to develop participant information will help to increase patient understanding of the ReStOre II trial and therefore recruitment and retention rates. The results of this SWAT will indicate the usefulness of this strategy for optimising recruitment to exercise rehabilitation trials in cancer survivorship. Registration: SWAT: Northern Ireland Hub for Trials Methodology Research SWAT Repository Store (SWAT-100). ReStOre II: ClinicalTrials.gov (NCT03958019).

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